Community Education and Surveillance on Antibiotics Use Among Young Children in Nepal: A Randomized Controlled Trial

Last registered on November 30, 2022

Pre-Trial

Trial Information

General Information

Title
Community Education and Surveillance on Antibiotics Use Among Young Children in Nepal: A Randomized Controlled Trial
RCT ID
AEARCTR-0010505
Initial registration date
November 27, 2022

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
November 30, 2022, 4:31 PM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

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Primary Investigator

Affiliation
Pennsylvania State University

Other Primary Investigator(s)

PI Affiliation
University of North Carolina at Chapel Hill

Additional Trial Information

Status
In development
Start date
2023-01-01
End date
2023-12-31
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
This study will test the effect of an educational intervention targeted to parents of young children on non-prescribed antibiotics consumption in Nepal. The outcomes will be tracked using a surveillance system designed specifically for this purpose.
External Link(s)

Registration Citation

Citation
Acharya, Yubraj and Prajwol Nepal. 2022. "Community Education and Surveillance on Antibiotics Use Among Young Children in Nepal: A Randomized Controlled Trial." AEA RCT Registry. November 30. https://doi.org/10.1257/rct.10505-1.0
Sponsors & Partners

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Experimental Details

Interventions

Intervention(s)
We will design and implement an education intervention targeted to parents of children ages 6 months to 10 years. We will track a number of outcomes related to antibiotics use and health care utilization over 6 months using a surveillance system specifically designed for this purpose.
Intervention Start Date
2023-01-01
Intervention End Date
2023-12-31

Primary Outcomes

Primary Outcomes (end points)
Non-prescribed antibiotics use among children ages 0-10 years

Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
--Health care use (specifically, visits to clinics and hospitals for care rather than a pharmacy)
--Expenditures on antibiotics and other medicines
--Adherence to dosage and duration of use for antibiotics.
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
The target population consists of parents of children ages 0-10 in Kathmandu, Bhaktapur and Lalitpur districts of the Kathmandu Valley. We randomly select 40 urban wards (from a list of 224 urban wards in these three districts) and randomly assign them to treatment and control arms (20 wards in each). Within the wards, we select households using systematic random sampling. We conduct a baseline survey and intervention in the treatment households. The outcomes will be tracked using a surveillance system designed for the study.
Experimental Design Details
Not available
Randomization Method
We will randomly select wards using a random number generator in Stata. We will assign the wards into treatment and control arms using Stata as well.
Randomization Unit
Ward
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
40 wards (20 each in treatment and control arms)
Sample size: planned number of observations
960 households
Sample size (or number of clusters) by treatment arms
480 households from 20 wards in treatment group. 480 households from 20 wards in the control group.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
In our previous study involving standardized patients, community pharmacies provided antibiotics without a physician prescription for pediatric diarrhea and URTI in 60 percent of the cases (average of diarrhea and URTI). In absence of prior data on antibiotics consumption at the household level, we assume that this proportion reflects household-level consumption of non-prescribed antibiotics. A 20 percentage point reduction in this proportion would be meaningful for policy, so we would like to be able to detect this difference at the 5% significance level with at least 80% power. There is no reason to believe that the intervention would have a negative effect—i.e., raise antibiotic consumption—so we base our calculation on a one-tail test. Our intervention will vary at the ward level to avoid contamination, with 20 households selected per ward. We assume a conservative intra-cluster correlation of 0.2. With these assumptions, we need a total of 760 households (380 households in each arm) from 40 wards (20 in each arm) for the final analysis. Our prior experience suggests that non-response and attrition are very low in this setting (in the vicinity of 10%). Nonetheless, we plan on a 20% attrition rate as the study requires participants to use a phone App. Therefore, we will recruit and enroll 480 households in each arm, for a total of 960 households in the study.
IRB

Institutional Review Boards (IRBs)

IRB Name
IRB Approval Date
IRB Approval Number